Senior Lead Quality urance Engineer

Medical Devices cl III - MDR combination devices

Join the Headquarter of an impressive independent Medical Devices company in Switzerland! Innovative implants registered as cl II-III medical devices are developed, manufactured and distributed on site.
Some of the exciting products are drug-device combination products!

Your Challenges

• Implement the new MDR in the regulatory processes with MDD considering for cl II III medical devices
• Prepare international submissions
• Develop and write clear arguments and explanations for new product certifications and license renewals
• Monitor and set timelines for certification and/or license variations and renewal approvals
• Provide input to project teams during the development of regulatory plans & filing strategy to ensure acceptable labelling in markets igned
• Provide regulatory intelligence information to the organization

Your Experience

• BSc/MSc degree in scientific discipline biology, chemistry, engineering or equivalent

• 3 years of experience in general regulatory affairs

• Experience with international medical device (cl II & III) regulatory approvals and submissions
• In depth knowledge on the new MDR and/or international regulations
• Strong project management

You are a collaborative, empathic and solution-oriented individual. Excellent command of spoken and written English is necessary, German knowledge is an et for internal communication. You provide adequate attention and support to internal departments. Your autonomy, your integrity, and your initiative are of high value. Interested? We are looking forward to get in touch with you.
Online application